The present invention relates to a composition for the treatment of hooves in (one- and/or two-) hoofed animals and a method for the treatment of hoofed animals.
The invention is also directed to a new and improved method for treating white line disease and hoof thrush in horses or in other equine animals susceptible to hoof thrush and white line disease and for treating hoof rot in sheep, goat and cattle. By xe2x80x9cequine animalsxe2x80x9d is meant a horse, donkey, mule, burro or zebra. However, the preferred animal is a horse. Hereinafter, the term xe2x80x9chorsexe2x80x9d encompasses all equine animals.
White line disease in horses is a disease that has not been very well documented. White line disease can cause severe discomfort for the horse and, if not well groomed, the horse will become cripple or lame.
The white line is generally considered to be that section of the hoof where the farrier places the nails when shoeing the horse. The white line disease is an affection of the stratum internum, which is the inside part of the hoof. The disease will cause a disruption of the white line, other than the disruption caused by normal influences from the outside such as small stones, sand and the like. The disruptions caused by such normal influences are usually superficial and will disappear upon regular trimming of the hoof. The white line disease generally tends to spread out more and deeper into the hoof. If the disease spreads out at proximal distance a void will form. The void will be surrounded by the horn of the stratum lamellatum on one side and the stratum internum or medium on the other side. This situation is commonly known as xe2x80x9chollow wallxe2x80x9d. The hoof then becomes brittle. The horse will experience considerable discomfort from this situation. The generally used remedy to limit the damage is regular and extensive trimming of the hooves. However, in many cases this does not solve the problem of white line disease.
By hoof thrush is meant a disease in horses of the hoof and frog tissue caused by a variety of pathogenic micro-organisms. By hoof rot is meant an analogous disease of the hoof in sheep, goats and cattle. The diagnostic signs of thrush disease or hoof rot include a strong unpleasant odour and discharge from the frog tissue. A veterinarian of ordinary skill can readily determine whether a horse exhibits a thrush infection or white line disease or whether a sheep, goat or cow exhibits a hoof rot infection.
A schematic drawing of the hoof is given in FIG. 1.
In an article in the xe2x80x9cTijdschrift voor Diergeneeskunde, 1995, 120, 18, pp 526-529xe2x80x9d, white line disease has been investigated in a population of horses in the Netherlands. A mycological investigation of the hoof material was carried out. It was found that Scopulariopsis brevicaulis was detected in 60% of the animals with an abnormal white line or with hollow wall or with seedy toe. The reported remedy against white line disease, hollow wall or seedy toe is based on the conventional treatment which is the extensive trimming of the hooves and removal of affected material. Other remedies or treatments are not given or suggested.
From WO89/07385 it is known that hoof thrush in horses and hoof rot in other animals is primarily caused by an anaerobic bacterium, Spherophorus necrophorus. The application describes a remedy based on the use of metronidazole (1-(2-hydroxyethyl)-2-methyl-5-nitroimidazole) in various forms and treatments.
It has now been found that a composition comprising a curing agent and a fungicide is very effective in the treatment of white line disease, hoof thrush and hoof rot. The invention thus relates to a composition for the topical treatment of hooves of one- and/or two-hoofed animals comprising a curing agent and a fungicide.
The curing agent in the composition is in general an agent which has a antiseptic and/or disinfecting effect. The curing agent, or caring agent, can also have other characteristics which can attribute to the well being of hooves. The active components in the curing agent are selected from the group consisting of bay leaf oil, medicinal turpentine oil, tea tree oil, lavender oil, bergamot oil, eucalyptus oil, pine oil, rosemary oil or mixtures and combinations thereof, preferably bay leaf oil, medicinal turpentine oil and/or tea tree oil or mixtures and combinations thereof. The curing agent is present in an amount up to 30 wt. %, preferably from 5 to 25 wt. %, more preferably from 10 to 20 wt. %. The fungicide in the composition can be any suitable fungicide as long as it is active against the fungus that is found in white line disease, hoof thrush or hoof rot. Preferably the fungicide expresses activity towards Scopulariopsis brevicaulis. The fungicide is selected preferably from the group consisting of enilconazole, clotrimazole, miconazole, sulconazole, econazole, oxiconazole, tioconazole, thiabendazole, naftifine, terbinafine, tolnaftate, itraconazole or mixtures and combinations thereof, preferably enilconazole, clotrimazole, miconazole or mixtures and combinations thereof. The fungicide is present in an amount up to 20 wt. %, preferably from 5 to 15 wt. %, more preferably from 7 to 12 wt. %. In a preferred embodiment the invention encompasses a composition for the topical treatment of hooves comprising
In different embodiments, such as an ointment, the composition may additionally comprise compounds such as a cetylester or like compounds. For use as a conditioner a basis composition can be prepared which can subsequently be diluted to a concentration that is suitable for application to the hoof. Alternatively the composition can be in the form of a gel. The previously described afflictions of hooves are also influenced by the presence of bacteria. If the hoof suffers from these afflictions, bacteria may enter the damaged areas and cause further infections. This will not only cause additional discomfort, but also have a detrimental influence on the healing process in general. To avoid this, it is possible and desirable to have a bactericide present in the composition according to the invention. The bactericide is preferably selected from the group consisting of chloroxylenols, triclosan, chlorhexidine, octopyrox or mixtures and combinations thereof, preferably triclosan and/or chloroxylenols or mixtures and combinations thereof. The fungicide is present in an amount up to 20 wt. %, preferably from 5 to 15 wt. %, more preferably from 7 to 12 wt. %. The composition can be provided in any suitable form such as a solution, emulsion, powder, ointment, spray, gel etcetera. The composition can be further brought in a suitable form by the addition of diluents, carriers, excipients, adjuvants, emulgators, dyes, colorants, perfumes and the like. The composition can also be mixed with known products for grooming or tending of hooves.
The present invention also relates to a method for treating white line disease, hoof thrush (in a horse) or hoof rot (in a sheep, goat or cow) comprising topically administering a therapeutically effective amount of the composition in a carrier directly on a thrush or hoof rot infected area for a treatment period effective to cure the thrush or hoof rot infection.
The present invention encompasses a method for the topical administration of the composition in the form of a solution or in the form of a gel, salve or ointment at and/or near the area affected by white line disease or the thrush or hoof rot infected area.
For topical administration in the form of a solution, the active drug component of the present invention, in liquid, powdered or lyophilised form may be combined with a suitable pharmaceutical diluent or carrier (collectively referred to herein as xe2x80x9ccarrierxe2x80x9d materials) such as water, saline, aqueous buffers, and the like. The method of application of the composition in the form of a solution may be by pouring, squirting, flushing or sponging the solution on the thrush or hoof rot infected area. In a preferred embodiment for treating thrush, a disposable plastic syringe (without a needle) may be filled with some of the composition solution for treatment and squirted on the thrush infected is area. Alternatively, the horse""s hoof may be submerged or immersed or soaked in the solution according to the invention to effect the treatment. In severe cases, such a soaking treatment may be necessary to effectively cure the thrush. In a preferred embodiment for treating hoof rot, the sheep, goat or cow is walked through a foot bath containing the solution.
The hooves of the animals in general are also carriers of bacteria and may even be infected by bacteria, for example by dung or faeces. When the same solution is used to treat different animals cross-contamination of the hooves between the animals may occur. The presence of the bactericide in the composition can also account for the prevention of cross-contamination.
For topical administration in the form of a gel, salve or ointment, the composition as above may be combined with a suitable carrier. The method of application of the composition in the form of a gel, salve or ointment may be by contacting and rubbing the gel, salve or ointment on, in, around and throughout the thrush hoof rot or white line disease infected areas of the animal""s hoof and frog.
Regardless of the form and method of administration selected (e.g. solution, gel, salve, ointment), the composition is formulated into pharmaceutically acceptable dosage forms by conventional methods known to those skilled in the art.
Regardless of the form and method of administration selected, a non-toxic but therapeutically effective amount of the composition is employed in any treatment. The dosage regimen for treating white line disease, hoof thrush or hoof rot is selected in accordance with a variety of factors, including the medical condition of the animal, the severity of the infection and the form of administration. A veterinarian of ordinary skill can readily determine and prescribe the effective amount required to cure the infection. In so proceeding, the veterinarian could employ relatively low doses at first and subsequently increase the dose until a maximum response is obtained.
With the composition according to the invention the treatment of hooves can effectively be achieved by treating horses over a period of, for instance, twelve to twenty weeks by a footbath three times a week during five or ten minutes. After that it is advantageously to apply a weekly footbath as a preventive treatment. An advantage of the invention is that the horn of the hooves improves in quality and the growth of horn is stimulated.
A composition according to the invention, wherein the active components are incorporated in an emulsion in water, is one wherein the composition comprises 5-10% bay leaf oil, 0.1-0.2% medicinal turpentine oil, 20-30% cetylester such as cetyl palmitate and/or cetylstearate, 5-8% miconazole or enilconazole or itraconazole, 20-30% of an emulgator such as a polysorbate and or a laurate, preferably sorbitollaurate in an organic solvent such as ethanol or methanol, the composition is diluted with about 50 parts of an aqueous solution.
A most preferred composition is one wherein the composition comprises 9% bay leaf oil, 0.15% medicinal turpentine oil, 23% cetylester such as cetyl palmitate or cetylstearate, 6.6% miconazole or enilconazole, or itraconazole, 25% of an emulgator such as a polysorbate and/or a laurate, preferably sorbitollaurate in an organic solvent such as ethanol or methanol, the composition is diluted with about 50 parts of an aqueous solution.
The invention also encompasses a method for the preparation of the composition according to the invention.
A preferred example of the method according to the invention comprises the steps of:
a. homogenising bay leaf oil, medicinal turpentine oil and cetylester;
b. homogenising miconazole or enilconazole or itraconazole with emulgator and solvent until a homogenous solution or suspension is obtained;
c. mixing and homogenising the mixtures obtained in the previous steps.
To obtain a composition which can be readily used, the following additional steps are performed:
d. mixing and homogenising a part of the composition obtained under c with an equal part of water with a temperature of 60-80xc2x0 C.;
e. adding, mixing and homogenising another two parts of water with a temperature of 60-80xc2x0 C.
It is to be noted other sources of ingredients or other ingredients than the above described can be used. For instance, by starting from the pure and commercially available compounds, the process for the preparation of the composition may deviate from the one herein described in a manner which is obvious to the man skilled in the art, without detracting from the gist of the invention. It is also possible to employ commercial available compositions comprising curing agents, fungicides and bactericides, respectively. The different compositions are mixed until a suitable homogenous composition is obtained by using variations of the process which variations are known to the man skilled in the art.
The obtained emulsion is diluted with 50 parts water and homogenised. A footbath is filled with this solution until a depth of about 5 cm. The horses are placed in the solution for a period of 5-10 minutes. It is advantageously to treat all horses, not only the horses with the afflictions as mentioned and to continue the treatment until all horses are free from the afflictions. After that it is advisory to continue the treatment on a more or less regular basis for instance every two weeks.
By not diluting the mixture obtained under e. an ointment is obtained which can be used as such.
The ointment can advantageously be used for the prevention of the mentioned afflictions by applying the ointment previously to the shooing of the horse.
The mixture and the solution prepared from the mixture can advantageously be used with sheep, goat and cow when hoof related infections or hoof rot occur.